Talking cervixes: How times materialise during the first stage of labour.

The clock occupies a prominent position in many feminist and midwifery critiques of the medicalisation of labour and birth. Concern has long focused on the production of standardised 'progress' during labour via the expectation that once in 'established' labour, birthing people's cervixes should dilate at a particular rate, measurable in centimetres and clock time. In this article we draw on 37 audio- or video-recordings of women labouring in two UK midwife-led units in NHS hospital settings to develop a more nuanced critique of the way in which times materialise during labour. Mobilising insights from literature that approaches time as relational we suggest that it is helpful to explore the making of times during labour as multiple, uncertain and open-ended. This moves analysis of time during labour and birth beyond concern with particular forms of time (such as the clock or the body) towards understanding how times are constituted through interactions (for example, between midwives, cervixes, clocks, people in labour and their birth partners), and what they do.

High prevalence of depression in parents of children with Type 1 diabetes in a meta-analysis of data from five continents.

AIM: This meta-analysis identified the prevalence of depression in parents of children with Type 1 diabetes. METHODS: MEDLINE, PsycINFO and CINAHL databases were searched for papers published in English from 1980 to May 2022, yielding 18 studies (N = 2044 participants). The prevalence of parental depression was pooled across the studies. RESULTS: The prevalence of depression among parents of children with Type 1 diabetes was high. Random-effects meta-analyses estimated the prevalence of moderate depression and above in the total sample as 18.4% (95% CI 12.8-24.6; k = 17, N = 2044), with rates of 17.3% in mothers (95% CI 12.7-22.5; k = 12, N = 1106) and 9% in fathers (95% CI 4.3-15.1; k = 6, N = 199). The estimated prevalence of mild depression and above in the total sample was 32.7% (95% CI 20.3-46.6; k = 8, N = 797), with rates of 29.4% in mothers (95% CI 17.8-42.6; k = 4 N = 330) and 13.6% in fathers (95% CI 5.2-25.2; k = 2 N = 44). All results were characterised by high levels of heterogeneity. The risk of publication bias was low. CONCLUSION: More than 1 in 6 parents of children with Type 1 diabetes had depression in the moderate plus category. The limitations and implications of these results are discussed.

Community based sociotherapy for depressive symptomatology of Congolese refugees in Rwanda and Uganda (CoSTAR): a protocol for a cluster randomised controlled trial.

Background: Conflict in the Democratic Republic of Congo has led to large numbers of refugees fleeing to Uganda and Rwanda. Refugees experience elevated levels of adverse events and daily stressors, which are associated with common mental health difficulties such as depression. The current cluster randomised controlled trial aims to investigate whether an adapted form of Community-based Sociotherapy (aCBS) is effective and cost-effective in reducing depressive symptomatology experienced by Congolese refugees in Uganda and Rwanda.Methods: A two-arm, single-blind cluster randomised controlled trial (cRCT) will be conducted in Kyangwali settlement, Uganda and Gihembe camp, Rwanda. Sixty-four clusters will be recruited and randomly assigned to either aCBS or Enhanced Care As Usual (ECAU). aCBS, a 15-session group-based intervention, will be facilitated by two people drawn from the refugee communities. The primary outcome measure will be self-reported levels of depressive symptomatology (PHQ-9) at 18-weeks post-randomisation. Secondary outcomes will include levels of mental health difficulties, subjective wellbeing, post-displacement stress, perceived social support, social capital, quality of life, and PTSD symptoms at 18-week and 32-week post-randomisation. Cost effectiveness of aCBS will be measured in terms of health care costs (cost per Disability Adjusted Life Year, DALY) compared to ECAU. A process evaluation will be undertaken to investigate the implementation of aCBS.Conclusion: This cRCT will be the first investigating aCBS for mental health difficulties experienced by refugees and will contribute to knowledge about the use of psychosocial interventions for refugees at a time when levels of forced migration are at a record high.Trial registration: ISRCTN.org identifier: ISRCTN20474555.

There is a need to evaluate community-based psychosocial interventions for refugees.Community-based sociotherapy has been used to support communities in post-conflict situations but has not been evaluated in a randomised controlled trial.This protocol outlines a proposed randomised controlled trial of community-based sociotherapy adapted for Congolese refugees in Uganda and Rwanda.

Factors influencing participation in randomised clinical trials among patients with early Barrett's neoplasia: a multicentre interview study.

OBJECTIVES: Strong recruitment and retention into randomised controlled trials involving invasive therapies is a matter of priority to ensure better achievement of trial aims. The BRIDE (Barrett's Randomised Intervention for Dysplasia by Endoscopy) Study investigated the feasibility of undertaking a multicentre randomised controlled trial comparing argon plasma coagulation and radiofrequency ablation, following endoscopic resection, for the management of early Barrett's neoplasia. This paper aims to identify factors influencing patients' participation in the BRIDE Study and determine their views regarding acceptability of a potential future trial comparing surgery with endotherapy. DESIGN: A semistructured telephone interview study was performed, including both patients who accepted and declined to participate in the BRIDE trial. Interview data were analysed using the constant comparison approach to identify recurring themes. SETTING: Interview participants were recruited from across six UK tertiary centres where the BRIDE trial was conducted. PARTICIPANTS: We interviewed 18 participants, including 11 participants in the BRIDE trial and 7 who declined. RESULTS: Four themes were identified centred around interviewees' decision to accept or decline participation in the BRIDE trial and a potential future trial comparing endotherapy with surgery: (1) influence of the recruitment process and participant-recruiter relationship; (2) participants' views of the design and aim of the study; (3) conditional altruism as a determining factor and (4) participants' perceptions of surgical risks versus less invasive treatments. CONCLUSION: We identified four main influences to optimising recruitment and retention to a randomised controlled trial comparing endotherapies in patients with early Barrett's-related neoplasia. These findings highlight the importance of qualitative research to inform the design of larger randomised controlled trials.

Is Solicitation of Problem Presentations Always Normative? How Chinese Patients Get to Present Their Reasons for Medical Visits.

Research based on recordings made across numerous specialties and geographical locations has characterized doctors' solicitations of patients' reasons for the visit as normative. However, in our dataset of 132 audio-recordings of consultations in Chinese primary and secondary care, it was as common for patients to self-initiate giving the reason for their visit as it was for doctors to solicit these (n = 65 vs. n = 67 respectively). Based on a conversation analytic examination of our dataset, we show that doctors do not treat patient-initiated problem presentations as deviant. Whilst there are some contextual contingencies (related, for example, to the queuing-system) that might account for this novel finding, these are only partly explanatory. Instead, we argue that, relative to Western contexts, the participants in our data treat the medical consultation as akin to a service-encounter in which patients are entitled to ask for what they want. Implications for understanding medical openings and health outcomes are discussed.

Effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss: a randomised feasibility trial (THE HUSH Trial).

BACKGROUND: Education and advice is provided for tinnitus management in all UK audiology clinics. Sound therapy, including provision of hearing aids may be offered, but this is often dependent on a clinician's decision rather than UK policy. This inconsistent management reflects a lack of evidence around the effectiveness of hearing aids for tinnitus. This open-label, two-arm multicentre randomised controlled feasibility trial gathered data around recruitment, acceptability and outcome assessments to determine the feasibility of conducting a large randomised controlled trial investigating the effectiveness of hearing aids for tinnitus management. METHODS: Adults referred to audiology for tinnitus, with an aidable hearing loss were recruited at five UK audiology clinics. They were randomised 1:1 to either education and advice (treatment as usual (TAU), n = 41) or TAU plus hearing aids (n = 42). Outcomes were collected by questionnaires 12 weeks after randomisation. After participation, interviews were conducted with a subset of both participants and clinicians from each trial centre. RESULTS: Eighty three participants from five sites were randomised. Non-aidable hearing loss was the main reason for ineligibility to participate in the trial reported by the sites. Seventy three percent of participants returned the 12-week questionnaires, with return rates by site ranging from 61 to 100%. Fifteen out of 33 participants (45%) reported using hearing aids for the clinician-recommended time, or longer, during the day. The Tinnitus Functional Index (TFI) was the outcome measure most responsive to change. The majority of participants also agreed it was relevant to their tinnitus and hearing loss. Qualitative data demonstrated that the trial was acceptable to participants. Feedback from clinicians revealed a potential lack of equipoise. It also highlighted the differences in referral and treatment pathways between departments and differences in audiometric criteria for fitting hearing aids. Health economic measures were well completed for those returned. No change in health-related quality of life was observed. Costs were higher in the intervention arm, but self-reports of healthcare service use indicated participant confusion in treatment pathways. CONCLUSIONS: This feasibility trial is the first step towards obtaining high quality evidence to determine potential clinical effectiveness and cost effectiveness of hearing aids for tinnitus versus usual care. A definitive trial was deemed to be feasible, with some modifications based on feasibility findings and using the TFI as the primary outcome. This trial was funded by the National Institute for Health Research, Research for Patient Benefit Programme (PB-PG-0816-20,014) and registered with ISRCTN (ISRCTN14218416).

Prospective validation of the 4C prognostic models for adults hospitalised with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol.

PURPOSE: To prospectively validate two risk scores to predict mortality (4C Mortality) and in-hospital deterioration (4C Deterioration) among adults hospitalised with COVID-19. METHODS: Prospective observational cohort study of adults (age ≥18 years) with confirmed or highly suspected COVID-19 recruited into the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) WHO Clinical Characterisation Protocol UK (CCP-UK) study in 306 hospitals across England, Scotland and Wales. Patients were recruited between 27 August 2020 and 17 February 2021, with at least 4 weeks follow-up before final data extraction. The main outcome measures were discrimination and calibration of models for in-hospital deterioration (defined as any requirement of ventilatory support or critical care, or death) and mortality, incorporating predefined subgroups. RESULTS: 76 588 participants were included, of whom 27 352 (37.4%) deteriorated and 12 581 (17.4%) died. Both the 4C Mortality (0.78 (0.77 to 0.78)) and 4C Deterioration scores (pooled C-statistic 0.76 (95% CI 0.75 to 0.77)) demonstrated consistent discrimination across all nine National Health Service regions, with similar performance metrics to the original validation cohorts. Calibration remained stable (4C Mortality: pooled slope 1.09, pooled calibration-in-the-large 0.12; 4C Deterioration: 1.00, -0.04), with no need for temporal recalibration during the second UK pandemic wave of hospital admissions. CONCLUSION: Both 4C risk stratification models demonstrate consistent performance to predict clinical deterioration and mortality in a large prospective second wave validation cohort of UK patients. Despite recent advances in the treatment and management of adults hospitalised with COVID-19, both scores can continue to inform clinical decision making. TRIAL REGISTRATION NUMBER: ISRCTN66726260.

Characterisation of in-hospital complications associated with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, multicentre cohort study.

BACKGROUND: COVID-19 is a multisystem disease and patients who survive might have in-hospital complications. These complications are likely to have important short-term and long-term consequences for patients, health-care utilisation, health-care system preparedness, and society amidst the ongoing COVID-19 pandemic. Our aim was to characterise the extent and effect of COVID-19 complications, particularly in those who survive, using the International Severe Acute Respiratory and Emerging Infections Consortium WHO Clinical Characterisation Protocol UK. METHODS: We did a prospective, multicentre cohort study in 302 UK health-care facilities. Adult patients aged 19 years or older, with confirmed or highly suspected SARS-CoV-2 infection leading to COVID-19 were included in the study. The primary outcome of this study was the incidence of in-hospital complications, defined as organ-specific diagnoses occurring alone or in addition to any hallmarks of COVID-19 illness. We used multilevel logistic regression and survival models to explore associations between these outcomes and in-hospital complications, age, and pre-existing comorbidities. FINDINGS: Between Jan 17 and Aug 4, 2020, 80 388 patients were included in the study. Of the patients admitted to hospital for management of COVID-19, 49·7% (36 367 of 73 197) had at least one complication. The mean age of our cohort was 71·1 years (SD 18·7), with 56·0% (41 025 of 73 197) being male and 81·0% (59 289 of 73 197) having at least one comorbidity. Males and those aged older than 60 years were most likely to have a complication (aged ≥60 years: 54·5% [16 579 of 30 416] in males and 48·2% [11 707 of 24 288] in females; aged <60 years: 48·8% [5179 of 10 609] in males and 36·6% [2814 of 7689] in females). Renal (24·3%, 17 752 of 73 197), complex respiratory (18·4%, 13 486 of 73 197), and systemic (16·3%, 11 895 of 73 197) complications were the most frequent. Cardiovascular (12·3%, 8973 of 73 197), neurological (4·3%, 3115 of 73 197), and gastrointestinal or liver (0·8%, 7901 of 73 197) complications were also reported. INTERPRETATION: Complications and worse functional outcomes in patients admitted to hospital with COVID-19 are high, even in young, previously healthy individuals. Acute complications are associated with reduced ability to self-care at discharge, with neurological complications being associated with the worst functional outcomes. COVID-19 complications are likely to cause a substantial strain on health and social care in the coming years. These data will help in the design and provision of services aimed at the post-hospitalisation care of patients with COVID-19. FUNDING: National Institute for Health Research and the UK Medical Research Council.

Residents' Perceptions of a Community-Led Intervention on Health, Well-Being, and Community Inclusion Through Photovoice.

Community-centered approaches can be effective ways to engage communities and improve their health and well-being. The Grange is a community-led, multifaceted, and dynamic intervention incorporating a community hub and garden, that took place in a small area of the North-West of England, characterized by high levels of deprivation and poor health. Activities have been defined, developed, and supported by residents to meet locally defined needs. This study used photovoice methods to explore residents' perceptions and experiences of this community-led intervention and any perceived impact on health, well-being, and community inclusion. Through photographs, semistructured interviews, a focus group discussion, and an exhibition, this study engaged intensively and creatively with a group of six residents. They identified positive and negative aspects related to The Grange and suggested recommendations that were directly communicated to policy makers during the photo-exhibition event. Participants reflected on various activities such as the community garden and the community shop. They also reflected on contextual factors and suggested that the culture of inclusivity and friendships associated with The Grange were more important to them than specific activities. This study demonstrated the value of using photovoice to (a) explore residents' perceptions of community led interventions; and (b) meaningfully engage residents living in areas with high levels of deprivation. Public health practitioners should consider the use of photovoice (a) in the evaluation of health interventions that take place in a complex and changing context, and (b) as a powerful tool to engage with members of the community, especially traditionally disadvantaged groups, to ensure that engagement about health, well-being, and social inclusion is meaningful.

Development and validation of the ISARIC 4C Deterioration model for adults hospitalised with COVID-19: a prospective cohort study.

BACKGROUND: Prognostic models to predict the risk of clinical deterioration in acute COVID-19 cases are urgently required to inform clinical management decisions. METHODS: We developed and validated a multivariable logistic regression model for in-hospital clinical deterioration (defined as any requirement of ventilatory support or critical care, or death) among consecutively hospitalised adults with highly suspected or confirmed COVID-19 who were prospectively recruited to the International Severe Acute Respiratory and Emerging Infections Consortium Coronavirus Clinical Characterisation Consortium (ISARIC4C) study across 260 hospitals in England, Scotland, and Wales. Candidate predictors that were specified a priori were considered for inclusion in the model on the basis of previous prognostic scores and emerging literature describing routinely measured biomarkers associated with COVID-19 prognosis. We used internal-external cross-validation to evaluate discrimination, calibration, and clinical utility across eight National Health Service (NHS) regions in the development cohort. We further validated the final model in held-out data from an additional NHS region (London). FINDINGS: 74 944 participants (recruited between Feb 6 and Aug 26, 2020) were included, of whom 31 924 (43·2%) of 73 948 with available outcomes met the composite clinical deterioration outcome. In internal-external cross-validation in the development cohort of 66 705 participants, the selected model (comprising 11 predictors routinely measured at the point of hospital admission) showed consistent discrimination, calibration, and clinical utility across all eight NHS regions. In held-out data from London (n=8239), the model showed a similarly consistent performance (C-statistic 0·77 [95% CI 0·76 to 0·78]; calibration-in-the-large 0·00 [-0·05 to 0·05]); calibration slope 0·96 [0·91 to 1·01]), and greater net benefit than any other reproducible prognostic model. INTERPRETATION: The 4C Deterioration model has strong potential for clinical utility and generalisability to predict clinical deterioration and inform decision making among adults hospitalised with COVID-19. FUNDING: National Institute for Health Research (NIHR), UK Medical Research Council, Wellcome Trust, Department for International Development, Bill & Melinda Gates Foundation, EU Platform for European Preparedness Against (Re-)emerging Epidemics, NIHR Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections at University of Liverpool, NIHR HPRU in Respiratory Infections at Imperial College London.

Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score.

OBJECTIVE: To develop and validate a pragmatic risk score to predict mortality in patients admitted to hospital with coronavirus disease 2019 (covid-19). DESIGN: Prospective observational cohort study. SETTING: International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) World Health Organization (WHO) Clinical Characterisation Protocol UK (CCP-UK) study (performed by the ISARIC Coronavirus Clinical Characterisation Consortium-ISARIC-4C) in 260 hospitals across England, Scotland, and Wales. Model training was performed on a cohort of patients recruited between 6 February and 20 May 2020, with validation conducted on a second cohort of patients recruited after model development between 21 May and 29 June 2020. PARTICIPANTS: Adults (age ≥18 years) admitted to hospital with covid-19 at least four weeks before final data extraction. MAIN OUTCOME MEASURE: In-hospital mortality. RESULTS: 35 463 patients were included in the derivation dataset (mortality rate 32.2%) and 22 361 in the validation dataset (mortality rate 30.1%). The final 4C Mortality Score included eight variables readily available at initial hospital assessment: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness, urea level, and C reactive protein (score range 0-21 points). The 4C Score showed high discrimination for mortality (derivation cohort: area under the receiver operating characteristic curve 0.79, 95% confidence interval 0.78 to 0.79; validation cohort: 0.77, 0.76 to 0.77) with excellent calibration (validation: calibration-in-the-large=0, slope=1.0). Patients with a score of at least 15 (n=4158, 19%) had a 62% mortality (positive predictive value 62%) compared with 1% mortality for those with a score of 3 or less (n=1650, 7%; negative predictive value 99%). Discriminatory performance was higher than 15 pre-existing risk stratification scores (area under the receiver operating characteristic curve range 0.61-0.76), with scores developed in other covid-19 cohorts often performing poorly (range 0.63-0.73). CONCLUSIONS: An easy-to-use risk stratification score has been developed and validated based on commonly available parameters at hospital presentation. The 4C Mortality Score outperformed existing scores, showed utility to directly inform clinical decision making, and can be used to stratify patients admitted to hospital with covid-19 into different management groups. The score should be further validated to determine its applicability in other populations. STUDY REGISTRATION: ISRCTN66726260.

Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study.

OBJECTIVE: To characterise the clinical features of patients admitted to hospital with coronavirus disease 2019 (covid-19) in the United Kingdom during the growth phase of the first wave of this outbreak who were enrolled in the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) World Health Organization (WHO) Clinical Characterisation Protocol UK (CCP-UK) study, and to explore risk factors associated with mortality in hospital. DESIGN: Prospective observational cohort study with rapid data gathering and near real time analysis. SETTING: 208 acute care hospitals in England, Wales, and Scotland between 6 February and 19 April 2020. A case report form developed by ISARIC and WHO was used to collect clinical data. A minimal follow-up time of two weeks (to 3 May 2020) allowed most patients to complete their hospital admission. PARTICIPANTS: 20 133 hospital inpatients with covid-19. MAIN OUTCOME MEASURES: Admission to critical care (high dependency unit or intensive care unit) and mortality in hospital. RESULTS: The median age of patients admitted to hospital with covid-19, or with a diagnosis of covid-19 made in hospital, was 73 years (interquartile range 58-82, range 0-104). More men were admitted than women (men 60%, n=12 068; women 40%, n=8065). The median duration of symptoms before admission was 4 days (interquartile range 1-8). The commonest comorbidities were chronic cardiac disease (31%, 5469/17 702), uncomplicated diabetes (21%, 3650/17 599), non-asthmatic chronic pulmonary disease (18%, 3128/17 634), and chronic kidney disease (16%, 2830/17 506); 23% (4161/18 525) had no reported major comorbidity. Overall, 41% (8199/20 133) of patients were discharged alive, 26% (5165/20 133) died, and 34% (6769/20 133) continued to receive care at the reporting date. 17% (3001/18 183) required admission to high dependency or intensive care units; of these, 28% (826/3001) were discharged alive, 32% (958/3001) died, and 41% (1217/3001) continued to receive care at the reporting date. Of those receiving mechanical ventilation, 17% (276/1658) were discharged alive, 37% (618/1658) died, and 46% (764/1658) remained in hospital. Increasing age, male sex, and comorbidities including chronic cardiac disease, non-asthmatic chronic pulmonary disease, chronic kidney disease, liver disease and obesity were associated with higher mortality in hospital. CONCLUSIONS: ISARIC WHO CCP-UK is a large prospective cohort study of patients in hospital with covid-19. The study continues to enrol at the time of this report. In study participants, mortality was high, independent risk factors were increasing age, male sex, and chronic comorbidity, including obesity. This study has shown the importance of pandemic preparedness and the need to maintain readiness to launch research studies in response to outbreaks. STUDY REGISTRATION: ISRCTN66726260.

A group intervention to improve quality of life for people with advanced dementia living in care homes: the Namaste feasibility cluster RCT.

BACKGROUND: People with advanced dementia who live and die in nursing homes experience variable quality of life, care and dying. There is a need to identify appropriate, cost-effective interventions that facilitate high-quality end-of-life care provision. OBJECTIVES: To establish the feasibility and acceptability to staff and family of conducting a cluster randomised controlled trial of the Namaste Care intervention for people with advanced dementia in nursing homes. DESIGN: The study had three phases: (1) realist review and (2) intervention refinement to inform the design of (3) a feasibility cluster randomised controlled trial with a process evaluation and economic analysis. Clusters (nursing homes) were randomised in a 3 : 1 ratio to intervention or control (usual care). The nature of the intervention meant that blinding was not possible. SETTING: Nursing homes in England providing care for people with dementia. PARTICIPANTS: Residents with advanced dementia (assessed as having a Functional Assessment Staging Test score of 6 or 7), their informal carers and nursing home staff. INTERVENTION: Namaste Care is a complex group intervention that provides structured personalised care in a dedicated space, focusing on enhancements to the physical environment, comfort management and sensory engagement. MAIN OUTCOME MEASURES: The two contender primary outcome measures were Comfort Assessment in Dying - End of Life Care in Dementia for quality of dying (dementia) and Quality of Life in Late Stage Dementia for quality of life. The secondary outcomes were as follows: person with dementia, sleep/activity (actigraphy), neuropsychiatric symptoms, agitation and pain; informal carers, satisfaction with care at the end of life; staff members, person-centred care assessment, satisfaction with care at the end of life and readiness for change; and other data - health economic outcomes, medication/service use and intervention activity. RESULTS: Phase 1 (realist review; 86 papers) identified that a key intervention component was the activities enabling the development of moments of connection. In phase 2, refinement of the intervention enabled the production of a user-friendly 16-page A4 booklet. In phase 3, eight nursing homes were recruited. Two homes withdrew before the intervention commenced; four intervention and two control homes completed the study. Residents with advanced dementia (n = 32) were recruited in intervention (n = 18) and control (n = 14) homes. Informal carers (total, n = 12: intervention, n = 5; control, n = 7) and 97 staff from eight sites (intervention, n = 75; control, n = 22) were recruited over a 6-month period. Recruitment is feasible. Completion rates of the primary outcome questionnaires were high at baseline (100%) and at 4 weeks (96.8%). The Quality of Life in Late Stage Dementia was more responsive to change over 24 weeks. Even where economic data were missing, these could be collected in a full trial. The intervention was acceptable; the dose varied depending on the staffing and physical environment of each care home. Staff and informal carers reported changes for the person with dementia in two ways: increased social engagement and greater calm. No adverse events related to the intervention were reported. CONCLUSIONS: A subsequent definitive trial is feasible if there are amendments to the recruitment process, outcome measure choice and intervention specification. FUTURE WORK: In a full trial, consideration is needed of the appropriate outcome measure that is sensitive to different participant responses, and of clear implementation principles for this person-centred intervention in a nursing home context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14948133. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 6. See the NIHR Journals Library website for further project information.

Namaste Care is a programme of respectful stimulation for nursing home residents who have advanced dementia. It is person-focused and reflects residents' individual likes and interests. It is claimed that Namaste Care improves quality of life for residents, family and staff, and quality of dying for residents, and can be provided without additional cost. This study explored how feasible it would be to conduct a large study in the future to understand the effects of Namaste Care on people with advanced dementia. Our literature review showed that Namaste Care enables people with advanced dementia to have moments of connection with others. We refined some Namaste Care resources through working with care home staff, family and volunteers to create a user-friendly booklet. Eight care homes were recruited to our 6-month trial; four homes were supported to introduce Namaste Care, two continued as usual and two withdrew. In the four intervention homes, residents with advanced dementia received Namaste Care. Staff used standard measures to assess (1) residents' responses and (2) the economic costs and benefits of Namaste Care. Researchers made observation visits. Records of activity in Namaste Care sessions were completed, and interviews were held with staff and family. Residents wore an ActiGraph (Activinsights Ltd, Kimbolton, UK) device that recorded their levels of sleep and activity. The length and frequency of Namaste Care sessions varied. Nursing homes incurred additional costs but could see ways to reduce those. All residents accepted wearing an ActiGraph device. Staff completed the data collection tools; some measures were more informative than others. Data from interviews showed that most people had positive experiences of Namaste Care. The findings support the view that Namaste Care has benefits for people with advanced dementia in nursing homes. We consider that, with some changes, this trial offers a model for a large study to show whether or not Namaste Care could be promoted more widely.

Variation and Interactional Non-Standardization in Neuropsychological Tests: The Case of the Addenbrooke's Cognitive Examination.

The Addenbrooke's Cognitive Examination (ACE-111) is a neuropsychological test used in clinical practice to inform a dementia diagnosis. The ACE-111 relies on standardized administration so that patients' scores can be interpreted by comparison with normative scores. The test is delivered and responded to in interaction between clinicians and patients, which places talk-in-interaction at the heart of its administration. In this article, conversation analysis (CA) is used to investigate how the ACE-111 is delivered in clinical practice. Based on analysis of 40 video/audio-recorded memory clinic consultations in which the ACE-111 was used, we have found that administrative standardization is rarely achieved in practice. There was evidence of both (a) interactional variation in the way the clinicians introduce the test and (b) interactional non-standardization during its implementation. We show that variation and interactional non-standardization have implications for patients' understanding and how they might respond to particular questions.

Following the patient's orders? Recommending vs. offering choice in neurology outpatient consultations.

The UK's Royal College of Surgeons (2016) has argued that health professionals must replace a 'paternalistic' approach to consent with 'informed choice'. We engage with these guidelines through analysis of neurology consultations in two UK-based neuroscience centres, where informed choice has been advocated for over a decade. Based on 223 recorded consultations and related questionnaire data (collected in 2012), we used conversation analysis (CA) to identify two practices for offering choice: patient view elicitors (PVEs) and option-lists. This paper reports further, mixed-methods analyses, combining CA with statistical techniques to compare the 'choice' practices with recommendations. Recommendations were overwhelmingly more common. There was little evidence that patient demographics determined whether choice was offered. Instead, decisional practices were associated with a range of clinical considerations. There was also evidence that individual neurologists tended to have a 'style', making it partly a matter of chance which decisional practice(s) patients encountered. This variability matters for the perception of choice: neurologists and patients were more likely to agree a choice had been offered if a PVE or option-list was used. It also matters for the outcome of the decision-making process: while recommendations nearly always ended in agreement to undertake the proffered course of action, option-lists and PVEs did so only about two-thirds of the time. While the direction of causality is unknown, this may indicate that patients are better enabled to refuse things they don't want when neurologists avoid recommending. We argue that our findings imply that neurologists tend to view choice as risky - in that the patient might make the 'wrong' choice - but that the inter-individual variation indicates that greater use of the more participatory practices is possible.

Healthcare professionals' assertions and women's responses during labour: A conversation analytic study of data from One born every minute.

OBJECTIVE: Communication during labour is consequential for women's experience yet analyses of situated labour-ward interaction are rare. This study demonstrates the value of explicating the interactional practices used to initiate 'decisions' during labour. METHODS: Interactions between 26 labouring women, their birth partners and HCPs were transcribed from the British television programme, One Born Every Minute. Conversation analysis was used to examine how decisions were initiated and accomplished in interaction. FINDINGS: HCPs initiate decision-making using interactional practices that vary the 'optionality' afforded labouring women in the responsive turn. Our focus here is on the minimisation of optionality through 'assertions'. An 'assertive' turn-design (e.g. 'we need to…') conveys strong expectation of agreement. HCPs assert decisions in contexts of risk but also in contexts of routine activities. Labouring women tend to acquiesce to assertions. CONCLUSION: The expectation of agreement set up by an assertive initiating turn can reduce women's opportunities to participate in shared decision-making (SDM). PRACTICE IMPLICATIONS: When decisions are asserted by HCPs there is a possible dissonance between the tenets of SDM in British health policy and what occurs in situ. This highlights an educational need for HCPs in how best to afford labouring women more optionality, particularly in low-risk contexts.

Large, mobile, transmitral metastastic osteosarcoma presenting as cardiac arrest.

UNLABELLED: The present case is an unusual one of a 21-year-old female with a primary osteosarcoma and left lung metastasis presenting following a witnessed pulseless electrical activity cardiac arrest. The electrocardiogram was unremarkable. A computed tomography pulmonary angiogram (CTPA) demonstrated a tumour within the left inferior pulmonary veins. Transthoracic echocardiography (TTE) revealed a severely hypokinetic left ventricle and a multi-lobulated, mobile mass arising from one of the left pulmonary veins which prolapsed to varying degrees on a beat-to-beat basis back and forth through the mitral valve into the left ventricle (during ventricular diastole) and retracted back into the left atrium (during ventricular systole). The present case demonstrates the importance of performing TTE in an emergency presentation, its influence on diagnosis and, in the present case, its usefulness in aiding the decision to withdraw life-sustaining treatments. It also highlights the importance of considering urgent intervention for a tumour seen to prolapse through the mitral valve because of the real risk of acute obstruction. LEARNING POINTS: The present case emphasises the importance of thorough clinical assessment in triggering TTE assessment in a critical care setting.TTE is a portable, radiation-free imaging modality that can aid rapid diagnosis in a deteriorating patient and guide an informed management plan.Many district general hospitals in the UK lack cardiology support and access to echocardiography 'out-of-hours'. TTE, in the hands of an experienced operator, is an invaluable tool in the emergency assessment and management of critically unwell patients and should be available 24 h a day, 7 days a week.Echosonographers and physicians seeing similar dynamic tumour pathology with variable transmission through the mitral valve should bear in mind acute obstruction as a potential consequence and thus consider urgent intervention.

Consent revisited: the impact of return of results on participants' views and expectations about trial participation.

BACKGROUND: Increasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants' perceptions of their original decision to consent. OBJECTIVE: We explored participants' views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial. METHOD: Semi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method. RESULTS: Participants' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust. CONCLUSIONS: Sharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption.

Unblinding following trial participation: qualitative study of participants' perspectives.

BACKGROUND: The implications of offering unblinding to trial participants to treatment arm after trial completion have been little explored. PURPOSE: We sought to explore trial participants' perspectives on whether they would like to be unblinded as to the treatment arm to which they were allocated following involvement in a large randomised controlled trial (RCT). METHODS: We conducted semi-structured interviews with 38 women who had participated in a trial during suspected preterm labour and had received the results of a long-term follow-up study that identified adverse outcomes for children in some of the treatment groups. Participants were sampled purposively. Analysis was based on the constant comparative method. RESULTS: Most women reported that they wanted to know the treatment arm to which they had been allocated. While the primary motive for some was curiosity, many others wanted to know as part of an attempt to understand or explain their child's current health problems. These women were motivated by a search for a coherent causal narrative, even though unblinding was unlikely to be able to meet their aspirations. Some participants identified potential disadvantages in discovering their treatment allocation, including feeling responsible for their child's health status, and some women were very clear that they did not want to know their treatment group. LIMITATIONS: A purposive sample was used and the extent to which it represents the views of all participants in the study is not established. CONCLUSIONS: Important challenges arise in offering to unblind trial participants, whatever the trial results. Participants may need help and support to understand the limitations of the knowledge they gain through being unblinded and to decide whether they wish to know to which treatment arm they were allocated.